Neurofeedback During Naturalistic Stimuli to Reduce Craving in Heroin Addiction

NCT07344233 — Not applicable, Completed, 28 participants, Icahn School of Medicine at Mount Sinai

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Brain-to-brain Neurofeedback During Naturalistic Dynamic Stimuli to Reduce Craving in Heroin Addiction

Registry	NCT07344233
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, sequential, masking: single, basic science
Enrollment	28 (Actual)
Sponsor	Icahn School of Medicine at Mount Sinai (Other); collaborators: National Institute on Drug Abuse (NIDA)
Conditions	Opioid Use Disorder, Substance Use Disorder, Heroin Use Disorder
Interventions	Real-time fMRI Neurofeedback, Sham Real-time fMRI Neurofeedback (Behavioral)
Dates	start 2025-05-20, primary completion 2025-08-31, completion 2025-08-31, first posted 2026-01-15, last updated 2026-10-21
Locations	1 site in United States

-Summary

Support groups are an important component of addiction treatment, where individuals at more stable stages of their recovery help others by sharing personal experiences. This phenomenon suggests that the brain states of individuals further along in their recovery process may be useful in guiding those who are at an earlier stage. In this project, the researchers will test this idea and develop a personalized therapeutic tool based on real-time fMRI neurofeedback, whereby individuals with heroin use disorder (iHUD) early in treatment will learn to modulate their own brain state to more closely align with iHUD who are at later stages of treatment. Specifically, iHUD exhibit heightened reactivity to naturalistic drug cues in brain networks underlying salience attribution, reward processing, executive function and others. This fMRI brain hyperactivity pattern is reduced, concomitant with craving reductions, with about 3 months of inpatient treatment. In this neurofeedback project, iHUD who are beginning treatment will view naturalistic drug cues and receive feedback about how similar their brain activity is to the target recovery pattern, learning to modulate their own brain activity to reduce drug cue reactivity and craving. This study will offer insights into the mechanisms of recovery in addiction, particularly as coordinated across individuals with shared experience and goals. If successful, the neurofeedback-based training may lead to new brain-based and personalized tools for recovery in this devastating disorder.

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+Arms and interventions

Arm	Type	Interventions	Description
Real Neurofeedback	Experimental	Behavioral: Real-time fMRI Neurofeedback	Participants receive real-time fMRI neurofeedback reflecting their own brain activity during a drug-related movie.
Sham (yolked) Neurofeedback	Sham comparator	Behavioral: Sham Real-time fMRI Neurofeedback	Participants receive sham real-time fMRI neurofeedback yoked to a matched participant and unrelated to their own brain activity.

Real-time fMRI Neurofeedback (Behavioral): Real-time feedback reflecting the similarity between participant's brain activity patterns and a predefined target while viewing a drug-related movie.
Sham Real-time fMRI Neurofeedback (Behavioral): Real-time feedback yoked to another participant and not reflective of the participant's own brain activity.

+Outcome measures

Primary outcomes

Cue/Movie-induced Craving Score [Immediately before and immediately after neurofeedback procedure (average 17 min MRI scan)]: Self-reported ratings of heroin craving on a 0-9 point scale, with higher scores indicating higher craving.

Secondary outcomes

Neurofeedback Score Change [During each 20 minute neurofeedback training session. Participants complete 8 neurofeedback sessions over the course of 4 consecutive days.]: Change in neurofeedback performance, reflecting participants' ability to modulate brain activity toward the predefined target pattern. Neurofeedback scores range 0-100, with higher scores indicating more similar brain activity to the target pattern.

+Eligibility

Sex: All, ages: 18 Years to 64 Years

Inclusion criteria:

* Ability to understand, give informed consent and perform the tasks
* males and females 18-64 years of age at the time of enrollment in the study
* DSM-5 diagnosis of opioid use disorder with heroin as the primary drug of choice
* currently enrolled in a treatment facility for heroin use as the primary concern
* 2-4 week abstinence from non-prescribed opioid use/stabilized on medication assisted therapy (MAT) using either methadone and/or buprenorphine.

Exclusion criteria:

* present or past history of a neurodevelopmental, neurological, or a psychotic disorder
* head trauma with loss of consciousness for more than 30 min
* use of medications (current or in the last 6 months) with known CNS effects which may alter cerebral function, with the exception of psychotropics for the treatment of pain/depression/anxiety/PTSD (e.g. SSRIs) or as otherwise determined by the Principle Investigator
* current medical illness and/or evident infection
* being pregnant or nursing
* contraindications to the MRI environment

+Posted results

Participant flow

Milestone	Real Neurofeedback	Sham (Yolked) Neurofeedback
Started	10	10
Completed	10	10
Not completed	0	0

Outcome results

Cue/Movie-induced Craving Score (Primary), Mean, score on a scale: Real Neurofeedback 3.0 +/- 2.75; Sham (Yolked) Neurofeedback 4.60 +/- 2.59
Neurofeedback Score Change (Secondary)

Adverse events

Time frame: From enrollment until end of last study visit, up to 10 weeks

Arm	Deaths	Serious adverse events	Other adverse events
Real Neurofeedback	0/10 (0.0%)	0/10 (0.0%)	0/10 (0.0%)
Sham (Yolked) Neurofeedback	0/10 (0.0%)	0/10 (0.0%)	0/10 (0.0%)

+Locations (1)

Facility	City	Country	Status
Icahn School of Medicine at Mount Sinai	New York, New York	United States

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2025-01-16)

+Investigators

Rita Goldstein, PhD, Principal investigator, NARC@mssm.edu

+Funding

NIH grants: R21DA058801